Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/31821
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Author(s): Bugge, Carol
Kearney, Rohna
Dembinsky, Melanie
Khunda, Aethele
Graham, Margaret
Agur, Wael
Breeman, Suzanne
Dwyer, Lucy
Elders, Andrew
Forrest, Mark
Goodman, Kirsteen
Guerrero, Karen
Hemming, Christine
Mason, Helen
McClurg, Doreen
Keywords: Process evaluation
Prolapse
Pessary
Self-management
Randomised controlled trial
Issue Date: Dec-2020
Citation: Bugge C, Kearney R, Dembinsky M, Khunda A, Graham M, Agur W, Breeman S, Dwyer L, Elders A, Forrest M, Goodman K, Guerrero K, Hemming C, Mason H & McClurg D (2020) The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation. Trials, 21 (1), Art. No.: 836. https://doi.org/10.1186/s13063-020-04729-w
Abstract: Background Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences. Methods The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. Discussion The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.
DOI Link: 10.1186/s13063-020-04729-w
Rights: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Notes: Additional co-authors: Lynn Melone, John Norrie, Ranee Thakar & Suzanne Hagen
Licence URL(s): http://creativecommons.org/licenses/by/4.0/

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